The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
详细描述
This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 20-40 years old
- •HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml
- •Gestational age: 26-28 weeks with normal fetus
- •Willing to consent for the study
排除标准
- •Elevated ALT
- •Antiviral treatment experience patients
- •Co-infection with HAV, HCV,HDV, HIV
- •Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
- •Clinical signs of threatened miscarriage in early pregnancy
- •Clinical evidence of cirrhosis and/or hepatocellular carcinoma
研究组 & 干预措施
Telbivudine
Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis
干预措施: Telbivudine (Drug)
Lamivudine
Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.
干预措施: Lamivudine (Drug)
结局指标
主要结局
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child
时间窗: From gestation week 26 to postpartum week 52
次要结局
- percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion(From gestation week 26 to pastpartume week 52)
研究者
Hua Zhang
Professor
Beijing YouAn Hospital